BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    ECG MODULATOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    APEX PS Knee

    FDA UDI
    Omni Life Science, Inc.·00841690113652·PS-C Insert, Size 4 x 12mm

    Fresh Cells

    FDA UDI
    DIAGNOSTIC HYBRIDS, INC.·30014613334651·SUPER E-MIX CELLS MWP W24/12F

    VISIOFOCUS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTOR

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ANGENIEUX

    FDA Adverse Event
    Malfunction ·MAQUET SAS·Product code FSY·June 3, 2014

    ISOFLEX 35X84 DARTEX W/FB

    FDA Adverse Event
    Injury ·STRYKER MEDICAL-KALAMAZOO·Product code FNM·January 18, 2013

    REVEAL DX

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code DSI·December 13, 2010

    Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.

    FDA Enforcement
    Class I ·Terminated·Animas Corporation·April 10, 2013